Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction

Randomized, Double-Blind, Placebo Controlled, Dose Ranging, Single Dose Comparison of Analgesic Efficacy and Safety of Intranasal Morphine, Immediate Release Oral Morphine, Intravenous Morphine and Placebo in Postsurgical Dental Pain

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00390312

Enrollment

225

Registered

2006-10-19

Start date

2001-09-30

Completion date

2001-11-30

Last updated

2008-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Operative Pain, Third Molar Extraction

Keywords

Post operative pain, Third molar extraction, Dental surgery, Morphine

Brief summary

This study involves approximately 200 patients designed to evaluate the efficacy and safety of intranasal (IN) morphine 7.5 mg and 15 mg, intravenous morphine (IV) 7.5 mg, immediate release oral (PO) morphine 60 mg or placebo in patients with acute postsurgical pain following third molar extraction.

Detailed description

Diagnosis and Main Criteria for Inclusion: Dental outpatients undergoing the removal of 3 or more third molars (2 of which were required to be mandibular and both must be bony impacted third molars).

Interventions

DRUGIntranasal Placebo

Intranasal placebo

DRUGIntranasal Morphine 15 mg

Intranasal Morphine 15 mg

DRUGImmediate Release Oral Morphine 60 mg

Immediate Release Oral Morphine 60 mg

DRUGIntravenous morphine

Intravenous morphine 7.5 mg

DRUGIntranasal morphine 7.5 mg

Intranasal morphine 7.5 mg

DRUGOral placebo

Oral placebo

DRUGIntravenous placebo

Intravenous placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Male or female 18-40 years of age * Surgical extraction of at least three or more third molars (two must be mandibular and both must be bony impacted third molars) * Moderate or severe pain within 6 hours of completion of surgery

Exclusion criteria

* Other oral surgical procedures during the same session except the removal of supernumerary third molars * Evidence of nasal congestion, nasal polyps, mucosal lesions of the nostrils, postnasal drip of any etiology or any clinically significant nasal pathology that may affect the absorption of study medication or the assessment of safety * Chronic respiratory insufficiency such that treatment with an opioid analgesic is contraindicated * Allergy to shellfish Additional Inclusion/

Design outcomes

Primary

Measure	Time frame
Total pain relief (TOTPAR) at the 0-2 hour time interval calculated as the time-weighted sum of the Pain Relief (PR) scores for the time interval 0-2 hours	2 hours

Secondary

Measure	Time frame
Other measures of pain relief	Several time points

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026